Renorma 2.5mg 10pcs

Indications

Treatment of symptoms caused by natural or surgical menopause in postmenopausal women. Prevent osteoporosis in women who have gone through menopause and are at high risk for fractures, but cannot take other medications to prevent osteoporosis.

Pharmacology

Tibolone is a synthetic steroid with the properties of estrogen, androgen, and progesterone. After oral administration, Tibolone is rapidly metabolized into three compounds, which contribute to the pharmacological effects of Tibolone. Two of the metabolites (3α-OH and 3β-OH metabolites) mainly have estrogenic activity; the third metabolite (the δ4 isomer of tibolone) and the parent compound mainly have progesterone and androgenic activities. Tibolone replaces the loss of estrogen production in postmenopausal women and reduces the symptoms of menopause. Prevent bone loss after menopause or oophorectomy. It has an estrogenic effect on the temperature regulation center (hot flashes) of the vagina, bones, and brain. Improve vaginal dryness and vaginal atrophy. Tibolone also has an effect on mood and sexual desire.

Dosage & Administration

The dose is one Tibolone tablet per day (2.5 mg daily). The tablet should be swallowed with some water or other drink, preferably at the same time each day. Improvement of symptoms generally occurs within a few weeks, but optimal results are obtained when therapy is continued for at least 3 months.

Starting Tibolone Tablet: Women experiencing natural menopause should commence treatment with Tibolone tablets at least 12 months after their last natural bleed. In case of surgical menopause, treatment with Tibolone tablets may commence immediately.

Switching from a sequential or continuous combined HRT (Hormone Replacement Therapy) preparation: If changing from a sequential HRT preparation, treatment with Tibolone should start the day following the completion of the prior regimen. If changing from a continuous-combined HRT preparation, treatment can start at any time.

Missed dose: A missed dose should be taken as soon as remembered unless it is more than 12 hours overdue. In the latter case, the missed dose should be skipped and the next dose should be taken at the normal time. Missing a dose may increase the likelihood of breakthrough bleeding and spotting

Interactions

In clinical practice, there are no reports of the interaction of tibolone with other drugs. However, the following potential interactions should be considered on a theoretical basis: Enzyme-inducing compounds such as barbiturates, carbamazepine, hydantoin, and rifampin may enhance the metabolism of tibolone, thus reducing its therapeutic effect. Since tibolone can increase blood or fibrinolytic activity (lower levels of fibrinogen; higher values ​​of AT III, plasminogen, and fibrinolytic activity), it can enhance the effect of anticoagulants.

Contraindications

It is contraindicated during pregnancy and lactation, known or suspected hormone-dependent tumors, cardiovascular and cerebrovascular diseases, active deep vein thrombosis, thromboembolic diseases, unexplained vaginal bleeding, and severe liver disease.

Side Effects

Occasionally, vaginal bleeding or spots may occur, mainly during the first few months of treatment. Other adverse reactions include headache and migraine, edema, dizziness, itching, weight gain, nausea, abdominal pain, rash, and depression.

Pregnancy & Lactation

Tibolone tablets are contraindicated during pregnancy. If you become pregnant while taking this product, you should stop treatment immediately. For this tablet, no clinical data on exposure to pregnancy are available. Tibolone tablets are contraindicated in lactating women.

Precautions & Warnings

Patients with kidney failure, liver disease, epilepsy, migraine, hypercholesterolemia, impaired carbohydrate metabolism, diabetes, and cholestatic jaundice.

Storage Conditions

Keep in a cool & dry place. Protect from light. Keep out of the reach of children.